Health care is evolving from “symptom-based” diagnostics to “molecular-based” in vitro diagnostics (IVD). Although IVD accounts for <1% of the annual US health care market, 70% of all clinical decisions are based on results from these tests. Their importance and complexity are growing with increasingly sophisticated and personalized medicine efforts.
Molecular diagnostics are a large contributor to the global IVD market currently accounting for 11% of the market. Unfortunately, the majority of these tests are expensive, involve slow turnaround times from centralized labs and require highly specialized equipment with seasoned technicians to carry out the assay. Therefore, a need exists for molecular platforms and streamlined assays to facilitate more timely and frequent monitoring of patient health to help realize personalized or precision medicine. Not only will new testing paradigms gradually displace centralized laboratory services as one moves to point-of-care testing, but new systems will greatly expand the total market demand for molecular diagnostics.
The present invention is directed at overcoming these and other deficiencies of the art.